510(k) K231005 ยท FXX Mask, Surgical
Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
| Applicant | Supermax Healthcare Canada-Supermax Medical, Saint-Bruno-De-Montarville, CA |
| Decision | Substantially Equivalent, Dec 5, 2023 |
| Received | Apr 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231005
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.